70management system standards comparison between iaea gsr3 and asme nqa12008 and nqa1a2009...

8/13/2019 70Management System Standards Comparison between IAEA GSR3 and ASME NQA12008 and NQA1a2009 Addend

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S a f e t y R e p o r t s S e r i e s

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IAEA SAFETY STANDARDS AND RELATED PUBLICATIONS

IAEA SAFETY STANDARDS

Under the terms of Article III of its Statute, the IAEA is authorized to establish or adopt

standards of safety for protection of health and minimization of danger to life and property, and

to provide for the application of these standards.

The publications by means of which the IAEA establishes standards are issued in the

IAEA Safety Standards Series. This series covers nuclear safety, radiation safety, transport

safety and waste safety. The publication categories in the series are Safety Fundamentals,

Safety Requirementsand Safety Guides.

Information on the IAEAs safety standards programme is available at the IAEA Internet

site

http://www-ns.iaea.org/standards/

The site provides the texts in English of published and draft safety standards. The texts

of safety standards issued in Arabic, Chinese, French, Russian and Spanish, the IAEA Safety

Glossary and a status report for safety standards under development are also available. For

further information, please contact the IAEA at PO Box 100, 1400 Vienna, Austria.

All users of IAEA safety standards are invited to inform the IAEA of experience in their

use (e.g. as a basis for national regulations, for safety reviews and for training courses) for the

purpose of ensuring that they continue to meet users needs. Information may be provided via

the IAEA Internet site or by post, as above, or by email to [email protected].

RELATED PUBLICATIONS

The IAEA provides for the application of the standards and, under the terms of Articles

III and VIII.C of its Statute, makes available and fosters the exchange of information relating

to peaceful nuclear activities and serves as an intermediary among its Member States for this

purpose.

Reports on safety and protection in nuclear activities are issued as Safety Reports,

which provide practical examples and detailed methods that can be used in support of the

safety standards.

Other safety related IAEA publications are issued as Radiological Assessment

Reports, the International Nuclear Safety Groups INSAG Reports, Technical Reportsand

TECDOCs. The IAEA also issues reports on radiological accidents, training manuals and

practical manuals, and other special safety related publications.

Security related publications are issued in the IAEA Nuclear Security Series.

The IAEA Nuclear Energy Seriesconsists of reports designed to encourage and assist

research on, and development and practical application of, nuclear energy for peaceful uses.

The information is presented in guides, reports on the status of technology and advances, and

best practices for peaceful uses of nuclear energy. The series complements the IAEAs safety

standards, and provides detailed guidance, experience, good practices and examples in the

areas of nuclear power, the nuclear fuel cycle, radioactive waste management and

decommissioning.


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MANAGEMENT SYSTEM STANDARDS:COMPARISON BETWEEN IAEA GS-R-3

AND ASME NQA-1-2008 ANDNQA-1a-2009 ADDENDA


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The following States are Members of the International Atomic Energy Agency:

The Agencys Statute was approved on 23 October 1956 by the Conference on the Statute of theIAEA held at United Nations Headquarters, New York; it entered into force on 29 July 1957. TheHeadquarters of the Agency are situated in Vienna. Its principal objective is to accelerate and enlarge thecontribution of atomic energy to peace, health and prosperity throughout the world.

AFGHANISTANALBANIAALGERIAANGOLAARGENTINAARMENIAAUSTRALIAAUSTRIAAZERBAIJANBAHRAINBANGLADESHBELARUSBELGIUMBELIZEBENINBOLIVIABOSNIA AND HERZEGOVINABOTSWANABRAZILBULGARIABURKINA FASOBURUNDICAMBODIACAMEROONCANADACENTRAL AFRICAN

REPUBLICCHADCHILECHINACOLOMBIACONGOCOSTA RICACTE DIVOIRECROATIACUBACYPRUSCZECH REPUBLICDEMOCRATIC REPUBLIC

OF THE CONGODENMARKDOMINICADOMINICAN REPUBLICECUADOREGYPTEL SALVADORERITREAESTONIAETHIOPIAFINLANDFRANCEGABONGEORGIAGERMANY

GHANAGREECEGUATEMALAHAITIHOLY SEEHONDURASHUNGARYICELANDINDIAINDONESIAIRAN, ISLAMIC REPUBLIC OFIRAQIRELANDISRAELITALYJAMAICAJAPANJORDANKAZAKHSTANKENYAKOREA, REPUBLIC OFKUWAITKYRGYZSTANLAO PEOPLES DEMOCRATIC

REPUBLICLATVIALEBANONLESOTHOLIBERIALIBYALIECHTENSTEINLITHUANIALUXEMBOURGMADAGASCARMALAWIMALAYSIAMALIMALTAMARSHALL ISLANDSMAURITANIAMAURITIUSMEXICOMONACO

MONGOLIAMONTENEGROMOROCCOMOZAMBIQUEMYANMARNAMIBIANEPALNETHERLANDSNEW ZEALANDNICARAGUANIGER

NIGERIANORWAYOMANPAKISTANPALAUPANAMAPAPUA NEW GUINEAPARAGUAYPERUPHILIPPINESPOLANDPORTUGALQATARREPUBLIC OF MOLDOVAROMANIARUSSIAN FEDERATION

SAUDI ARABIASENEGALSERBIASEYCHELLESSIERRA LEONESINGAPORESLOVAKIASLOVENIASOUTH AFRICASPAINSRI LANKASUDANSWEDEN

SWITZERLANDSYRIAN ARAB REPUBLICTAJIKISTANTHAILANDTHE FORMER YUGOSLAV

REPUBLIC OF MACEDONIATUNISIATURKEYUGANDAUKRAINEUNITED ARAB EMIRATESUNITED KINGDOM OF

GREAT BRITAIN AND

NORTHERN IRELANDUNITED REPUBLIC

OF TANZANIAUNITED STATES OF AMERICAURUGUAYUZBEKISTANVENEZUELAVIETNAMYEMENZAMBIAZIMBABWE


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MANAGEMENT SYSTEM STANDARDS:COMPARISON BETWEEN IAEA GS-R-3

AND ASME NQA-1-2008 AND

NQA-1a-2009 ADDENDA

INTERNATIONAL ATOMIC ENERGY AGENCYVIENNA, 2012

SAFETY REPORTS SERIES No. 70


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IAEA Library Cataloguing in Publication Data

Management system standards : comparison between IAEA GS-R-3 and ASMENQA-1-2008 and NAQ-1a-2009 Addenda. Vienna : InternationalAtomic Energy Agency, 2012.

p. ; 24 cm. (Safety reports series, ISSN 10206450 ; no. 70)STI/PUB/1530ISBN 9789201208101Includes bibliographical references.

1. Nuclear facilities Management. 2. Radiation Safety measures.3. Nuclear facilities Reliability. I. International Atomic Energy Agency.II. Series.

IAEAL 1200738

COPYRIGHT NOTICE

All IAEA scientific and technical publications are protected by the terms ofthe Universal Copyright Convention as adopted in 1952 (Berne) and as revised in1972 (Paris). The copyright has since been extended by the World IntellectualProperty Organization (Geneva) to include electronic and virtual intellectualproperty. Permission to use whole or parts of texts contained in IAEApublications in printed or electronic form must be obtained and is usually subjectto royalty agreements. Proposals for non-commercial reproductions andtranslations are welcomed and considered on a case-by-case basis. Enquiriesshould be addressed to the IAEA Publishing Section at:

Marketing and Sales Unit, Publishing SectionInternational Atomic Energy AgencyVienna International CentrePO Box 1001400 Vienna, Austriafax: +43 1 2600 29302tel.: +43 1 2600 22417email: [email protected]

http://www.iaea.org/books

IAEA, 2012

Printed by the IAEA in AustriaMay 2012

STI/PUB/1530


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FOREWORD

IAEA safety standards reflect an international consensus on whatconstitutes a high level of safety for protecting people and the environment. Theyoften serve as safety regulatory documents. In practice, to be fully effective theIAEA safety standards need to be complemented by industry standards and mustbe implemented within an appropriate national regulatory infrastructure. TheIAEA produces a wide range of technical publications and reports to helpMember States in developing this national infrastructure and the associatedstandards.

IAEA Safety Standards Series No. GS-R-3, The Management System forFacilities and Activities (IAEA GS-R-3), defines the requirements for

establishing, implementing, assessing and continually improving a managementsystem. A management system designed to fulfil these requirements integratessafety, health, environmental, security, quality and economic elements. IAEAGS-R-3, together with its supporting Safety Guides, supersedes Safety SeriesNo. 50-C/SG-Q, Quality Assurance for Safety in Nuclear Power Plants and otherNuclear Installations.

IAEA GS-R-3 requirements are applicable to the management systems ofoperating organizations, designers and suppliers. Moreover, IAEA GS-R-3 can beused as the basis for the management systems of the relevant regulatory bodies.

IAEA GS-R-3 also requires the identification and integration of any requirementsformally agreed with interested parties such as regulators, suppliers andcustomers. These formally agreed requirements can include one or more nationaland international codes and standards. Quality Assurance Requirements forNuclear Facility Applications (ASME NQA-1-2008 and NQA-1a-2009Addenda), developed by the American Society of Mechanical Engineers(ASME), is an example of such a standard. It is the ninth edition of the ASMENQA-1 series of nuclear quality assurance level 1 standards, published as ASMENQA-1-2008, with the 2009 1a Addenda, published as ASME NQA-1a-2009.

ASME NQA-1-2008 and NQA-1a-2009 Addenda (referred to hereinaftersimply as ASME NQA-1) is a national consensus standard that specifiesrequirements for a quality assurance programme. The purpose of the qualityassurance programme is to achieve safe, reliable and efficient utilization ofnuclear energy and management and processing of radioactive materials.

The present publication compares the requirements of IAEA GS-R-3 andASME NQA-1 and identifies similarities and differences between them. Theobjective is to provide information and guidance to assist an organization to meet

the requirements of both standards. This report extends the guidance developedby the IAEA on making the transition from quality management systems to(integrated) management systems based on IAEA GS-R-3.


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In this publication, should statements are used to provide guidance basedon expert judgement; they do not stem from a consensus of IAEA Member States.The guidance provided does not relieve the users of their responsibility to complywith the requirements of the standards.

The IAEA wishes to thank the contributors to this Safety Report for theirefforts and valuable assistance. The IAEA officers responsible for thispublication were J. Majola and J.P. Boogaard of the Division of Nuclear Power.

EDITORIAL NOTE

Although great care has been taken to maintain the accuracy of information contained

in this publication, neither the IAEA nor its Member States assume any responsibility for

consequences which may arise from its use.

The use of particular designations of countries or territories does not imply any

judgement by the publisher, the IAEA, as to the legal status of such countries or territories, of

their authorities and institutions or of the delimitation of their boundaries.The mention of names of specific companies or products (whether or not indicated as

registered) does not imply any intention to infringe proprietary rights, nor should it be

construed as an endorsement or recommendation on the part of the IAEA.


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CONTENTS

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.1. Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.2. Objective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21.3. Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21.4. Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21.5. Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2. APPLICATION OF IAEA GS-R-3 ANDASME NQA-1 STANDARDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2.1. Objectives of IAEA GS-R-3 and ASME NQA-1 . . . . . . . . . . . 32.2. Scope and approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42.3. Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3. EXTENT TO WHICH IAEA GS-R-3 ADDRESSESASME NQA-1 REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

4. EXTENT TO WHICH ASME NQA-1 ADDRESSESIAEA GS-R-3 REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

4.1. Management system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334.1.1. Safety culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334.1.2. Management commitment . . . . . . . . . . . . . . . . . . . . . . . 344.1.3. Satisfaction of interested parties . . . . . . . . . . . . . . . . . . 344.1.4. Organizational policies . . . . . . . . . . . . . . . . . . . . . . . . . . 344.1.5. Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 344.1.6. Responsibility, authority and communication . . . . . . . . 34

4.1.7. Provision of resources . . . . . . . . . . . . . . . . . . . . . . . . . . 354.1.8. Developing processes . . . . . . . . . . . . . . . . . . . . . . . . . . . 354.1.9. Process management . . . . . . . . . . . . . . . . . . . . . . . . . . . 354.1.10. Generic management system processes . . . . . . . . . . . . 364.1.11. Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 364.1.12. Managing organizational change . . . . . . . . . . . . . . . . . 364.1.13. Self-assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 364.1.14. Management system review . . . . . . . . . . . . . . . . . . . . . 364.1.15. Non-conformances and corrective and

preventive actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 374.1.16. Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37


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APPENDIX I: CORRELATION BETWEEN THE REQUIREMENTSOF IAEA GS-R-3 AND THOSE OF ASME NQA-1 . . . . 57

APPENDIX II: CORRELATION BETWEEN THE REQUIREMENTSOF ASME NQA-1 AND THOSE OF IAEA GS-R-3 . . . . 58

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59CONTRIBUTORS TO DRAFTING AND REVIEW . . . . . . . . . . . . . . . . . 61


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1. INTRODUCTION

1.1. BACKGROUND

The IAEA Safety Requirements publication on The Management Systemfor Facilities and Activities, IAEA Safety Standards Series No. GS-R-3 [1](IAEA GS-R-3), defines the requirements for establishing, implementing,assessing and continually improving a management system for facilities andactivities that integrates safety, health, environmental, security, quality andeconomic elements. The IAEA Safety Guides on the Application of theManagement System for Facilities and Activities [2] and on The Management

System for Nuclear Installations [3], as well as other IAEA Safety Guidesspecific to technical areas, provide recommendations on how to fulfil therequirements specified in IAEA GS-R-3.

The management systems of operators or organizations that provide nuclearitems or products and services must comply with safety requirements, includingthose prescribed in IAEA safety standards (e.g. IAEA GS-R-3) that are adoptedby Member States. The utility or owner/operator of a nuclear facility orinstallation has the ultimate responsibility to ensure that the management systemimplemented provides for an adequate level of safety. IAEA GS-R-3 helps an

organization to put in place a management system that fosters a strong safetyculture and improves safety performance.

As Member States adopt and apply IAEA GS-R-3 requirements, regulatorybodies, operators or organizations providing nuclear items or products andservices may be required to comply with the safety requirements in these IAEAstandards while maintaining the certification or compliance of their items,products and services under ASME NQA-1-2008 and the 2009 1a Addendapublished as ASME NQA-1a-2009 [4] (hereinafter referred to as ASME NQA-1)or other relevant codes and standards. Consequently, an organization may adoptIAEA GS-R-3 and ASME NQA-1 as the basis of its management system. IAEAGS-R-3 requires these requirements to be integrated within one managementsystem. Therefore, the present guidance was developed to assist organizations tosatisfy these requirements.


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This publication helps organizations by providing information on thesimilarities and differences between IAEA GS-R-3 and ASME NQA-1. Itcomplements other IAEA publications1 that compare the requirements ofmanagement system standards.

1.2. OBJECTIVE

The objective of this Safety Report is to compare the requirements of IAEAGS-R-3 with those of ASME NQA-1, to identify the similarities and differencesbetween them and to provide information and guidance to assist an organizationto meet the requirements of both standards.

1.3. SCOPE

This publication compares the requirements in the following publications:

IAEA Safety Standards Series No. GS-R-3, The Management System forFacilities and Activities [1];

ASME NQA-1, Quality Assurance Requirements for Nuclear Facility

Applications [4], Part I.

1.4. USERS

This publication is intended for:

Regulatory bodies and customers who require, through regulation orcontract, the management systems for nuclear facilities and activities tocomply with the requirements of IAEA GS-R-3 and ASME NQA-1;

Operators of nuclear facilities and activities who are either legally obliged,or choose as best practice, to implement the requirements of IAEA GS-R-3and ASME NQA-1;

1 These publications include: IAEA Safety Reports Series No. 69 comparison betweenIAEA GS-R-3 and ISO 9001:2008 [5], and the comparison between IAEA Safety SeriesNo. 50-C/SG-Q (Quality Assurance for Safety in Nuclear Power Plants and other Nuclear

Installations [6]) and the ISO standards, reported in IAEA-TECDOC-1182 [7] and QualityStandards: Comparison between IAEA 50-C/SG-Q and ISO 9001:2000, IAEA Safety ReportsSeries No. 22 [8].


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Suppliers of products or services that are required to be produced inaccordance with the requirements of IAEA GS-R-3 and ASME NQA-1.

1.5. STRUCTURE

The present publication is structured as follows: Section 2 provides ageneral description of the application of, and differences between, the IAEAGS-R-3 and ASME NQA-1 standards. Section 3 describes the extent to whichIAEA GS-R-3 addresses ASME NQA-1 requirements and includes a tablepresenting the two standards and comparing them using the process approach ofIAEA GS-R-3. Section 4 describes the extent to which ASME NQA-1 addresses

the IAEA GS-R-3 requirements and includes a table presenting the two standardsand comparing them using the 18 criteria format of ASME NQA-1 [4], Part I.Appendix I provides a correlation matrix for IAEA GS-R-3 users showing

the correspondence between the requirements in IAEA GS-R-3 and those inASME NQA-1; Appendix II provides a correlation matrix for ASME NQA-1users showing the correspondence between the requirements in ASME NQA-1and those in IAEA GS-R-3.

2. APPLICATION OF IAEA GS-R-3AND ASME NQA-1 STANDARDS

2.1. OBJECTIVES OF IAEA GS-R-3 AND ASME NQA-1

IAEA GS-R-3 defines requirements for an organization to establish,implement, assess and continually improve a management system that integratessafety, health, environmental, security, quality and economic elements to ensurethat safety is not compromised. It reflects an international consensus on whatconstitutes an effective, integrated, safety focused management system fornuclear facilities and activities. It fosters a strong safety culture and improvedsafety performance in all the activities of the organization.

ASME NQA-1 defines requirements for an organization to establish,implement and assess a quality assurance (QA) programme to achieve nuclear

safety. ASME NQA-1 reflects industry experience and current understanding ofQA requirements for the safe, reliable and efficient utilization of nuclear energyand management and processing of radioactive materials.


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2.2. SCOPE AND APPROACH

IAEA GS-R-3 and ASME NQA-1 apply to the entire life cycle of nuclearfacilities and activities, including siting, design, construction, commissioning,operation and decommissioning. Both standards foster the application ofrequirements in a manner that is consistent with the relative importance of theitem or activity to safety.

IAEA GS-R-3 adopts an integrated management system approach to beapplied to all work of the organization. It requires the integration of safety, health,environmental, security, quality and economic elements of the management systemto ensure that safety is properly taken into account in all activities. It specifiesrequirements designed to achieve and enhance safety, while enhancing the

satisfaction of interested parties. A management system based on IAEA GS-R-3includes a process approach to achieve the objectives, and continual improvementof the management system and its processes, in which all safety, quality,environmental, security and economic aspects are integrated to preclude a negativeimpact on safety. A management system based on IAEA GS-R-3, the objective ofwhich is to achieve and enhance safety, also includes safety culture, gradingdocumentation and human performance. Safety Guides GS-G-3.1 [2] and GS-G-3.5 [3] give detailed guidance on how the requirements of IAEA GS-R-3 can bemet.

The ASME NQA-1 approach applies QA requirements to activities that couldaffect the quality of nuclear material applications and of structures, systems and

components of nuclear facilities. Quality assurance requirements are used to develop

a QA programme necessary to achieve safe, reliable and efficient utilization of

nuclear energy and management and processing of radioactive material.

ASME NQA-1 was originally developed to implement QA requirements for

nuclear power plant design and construction in the United States of America. ASME

NQA-1 now applies expanded QA requirements to a range of nuclear facilities to

address new technologies and safety issues. ASME NQA-1 does not require an

integrated management system approach, as is required by IAEA GS-R-3.

2.3. APPLICATION

IAEA GS-R-3 can be used by Member States to set management systemrequirements for nuclear facilities and activities, to provide assurance that safetycan be achieved and enhanced. ASME NQA-1 can be imposed by a regulatory

body through regulation or national codes and standards. It can be used by anuclear facility to meet quality requirements set by a regulatory body. Both IAEAGS-R-3 and ASME NQA-1 can be invoked by contract, adopted voluntarily, or


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used as the basis for assessing a management system or a QA programme. Thesestandards require that responsibility for the management system and for workcarried out under the management system be retained by the organization.Figure 1 provides an example of how the standards can be applied.

Guidance on evaluating existing practices or supplementing the standard issummarized in the text preceding Table 1 in Section 3 and Table 2 in Section 4. Inmost cases, the IAEA requirements are stated at a higher, process level and the usermust determine the need to develop detailed practices for implementation of theASME NQA-1 [4] requirements. In these cases, it is necessary to compare existingpractices with the requirements of ASME NQA-1 [4] to determine additionalrequirements for compliance.

Requirement path

Compliance or satisfaction path

Regulatory requirements

(can include IAEA GS-R-3 and

ASME NQA-1)

REGULATORY BODY

SUPPLIER

Contractual requirements

(can include IAEA GS-R-3 and

ASME NQA-1)

OWNER/OPERATOR

of NUCLEAR FACILITY

or ACTIVITY

Legal and statutory

e.g. national lawscan include IAEA GS-R-3

GOVERNMENT

requirements

FIG. 1. Application of IAEA GS-R-3 and ASME NQA-1.


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3. EXTENT TO WHICH IAEA GS-R-3 ADDRESSESASME NQA-1 REQUIREMENTS

This section describes the extent to which IAEA GS-R-3 addresses theASME NQA-1 requirements. It identifies where the requirements are equivalentand provides guidance on how to modify an IAEA GS-R-3 management systemto integrate ASME NQA-1 requirements. Table 1 presents the requirements ofASME NQA-1, Part I, on a line-by-line basis, for all 18 requirements, as well asthe subparagraphs of each requirement. Immediately adjacent to the ASMENQA-1 requirement, the corresponding IAEA GS-R-3 requirement is presented.In cases where IAEA GS-R-3 does not specifically meet the ASME NQA-1

requirement, guidance is provided on how best to meet the ASME NQA-1requirement with IAEA GS-R-3 as a basis. Table 1 provides guidance on how theIAEA GS-R-3 user can meet the ASME NQA-1 requirement. The correlationbetween the requirements in IAEA GS-R-3 and those in ASME NQA-1 ispresented in Appendix I.

The following presents those ASME NQA-1 requirements for which thereis No corresponding requirement in IAEA GS-R-3, as identified in Table 1. Thenumbering corresponds to the ASME NQA-1 requirement and section.

REQUIREMENT 2: QUALITY ASSURANCE PROGRAMME

2-300 Qualification requirements

ASME NQA-1 requires the organization to designate activities that requirequalification. The minimum requirements for personnel to verify quality and toconduct audits are specified in paragraphs 301305 of this section of the ASMEstandard.

2-400 Records of qualification

ASME NQA-1 requires the organization to ensure the qualification ofinspection, test and lead auditor(s), and to ensure that their certification is inwriting according to the requirements specified in this section of the ASMEstandard.


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REQUIREMENT 3: DESIGN CONTROL

ASME NQA-1 requires the organization to implement requirements fordesign control. IAEA GS-R-3 does not contain specific requirements for designcontrol, but IAEA GS-R-3 Requirements 5.15.10 address development,implementation and management of processes in general, and these also apply toprocesses for design control.

3-800 Software design control

ASME NQA-1 has a specific requirement for software design control; inIAEA GS-R-3, this is implicitly required by the general requirements for process

implementation (see paras 5.15.10).

REQUIREMENT 4: PROCUREMENT DOCUMENT CONTROL

4-300 Procurement document review

ASME NQA-1 explicitly requires the organization to implementrequirements for the review of procurement documents.

REQUIREMENT 7: CONTROL OF PURCHASED ITEMS AND SERVICES

7-300 Bid evaluation

ASME NQA-1 explicitly requires the organization to implementrequirements for bid evaluation including determination of the supplierscapability.

7-400 Control of supplier generated documents

ASME NQA-1 explicitly requires the organization to implementrequirements for the submission and evaluation of supplier generated documentsand changes to ensure that they are accomplished in accordance with theprocurement document requirements.


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7-700 Commercial grade items and services

ASME NQA-1 requires the organization to implement requirements for theutilization of commercial grade items or services.

7-800 Records

ASME NQA-1 requires the organization to implement requirements forrecords for the control of purchased items and services. IAEA GS-R-3 specifiesthe requirements for control of records in general.

REQUIREMENT 8: IDENTIFICATIONAND CONTROL OF ITEMS

8-200 Identification methods

ASME NQA-1 requires the organization to implement requirements for thephysical identification of items, for how they are to be used to the maximumextent possible and for how they relate to an applicable design or other pertinentspecifying document.

8-300 Specific requirements

ASME NQA-1 requires the organization to implement requirements for thecontrol of item identification consistent with the planned duration and conditionsof storage.

REQUIREMENT 9: CONTROL OF SPECIAL PROCESSES

ASME NQA-1 requires the organization to implement requirements for thecontrol of special processes.

9-100 Basic

ASME NQA-1 requires the organization to implement requirements forspecial processes that control or verify the quality of special activities such aswelding, heat treatment and non-destructive examination.


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9-200 Process control

ASME NQA-1 requires the organization to control the defined specialprocesses by instructions, procedures, drawings, checklists or other appropriatemeans.

9-300 Responsibility

ASME NQA-1 requires the organization to adhere to the approvedprocedures and processes when performing special processes.

9-400 Records

ASME NQA-1 requires the organization to implement special processes tomaintain records, as appropriate, of the qualified personnel, processes andequipment used in each special process.

REQUIREMENT 10: INSPECTION

10-300 Inspection hold points

ASME NQA-1 requires the organization to implement requirements formandatory inspection hold points beyond which work shall not proceed.

10-400 Inspection planning

ASME NQA-1 requires the organization to identify characteristics to beinspected, methods of inspection, acceptance criteria and methods of samplingduring inspection planning.

10-500 In-process inspection

ASME NQA-1 explicitly requires the organization to implementrequirements for the inspection of items under construction or otherwise inprocess, to verify quality.

10-600 Final inspections

ASME NQA-1 explicitly requires the organization to inspect completeditems, re-inspect or retest any modified, repaired or replaced item, approve


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acceptance of the item and review the results of inspection and of the resolutionof non-conformances.

10-700 Inspections during operations

ASME NQA-1 requires the organization to plan and execute periodicinspections (e.g. in-service inspections) or surveillance of structures, systems orcomponents, to ensure the continued performance of their required functions.

10-800 Records

ASME NQA-1 requires the organization to establish and maintain

inspection records, and identifies minimum contents for these records.

REQUIREMENT 11: TEST CONTROL

11-200 Test requirements

ASME NQA-1 requires the organization to establish test requirements andacceptance criteria.

11-300 Test procedures (other than for computer programs)

ASME NQA-1 requires the organization to ensure that test proceduresinclude or reference the test configuration and test objectives.

11-400 Computer program test procedures

ASME NQA-1 requires the organization to ensure that computer programtest procedures provide for demonstrating the adherence of the computer programto documented requirements.

11-500 Test result

ASME NQA-1 requires the organization to document, maintain andevaluate test results, using a responsible authority to ensure that test requirementshave been satisfied.


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11-600 Test records

ASME NQA-1 requires the organization to establish and maintain testrecords.

REQUIREMENT 12: CONTROL OF MEASURING AND TEST EQUIPMENT

12-300 Calibration and control

ASME NQA-1 requires the organization to calibrate measuring and testequipment using reference standards and control procedures.

12-400 Records

ASME NQA-1 requires the organization to establish and maintaincalibration records, including calibration reports and certificates that include theinformation and data necessary for interpretation of the calibration results andverification of conformance with applicable requirements.

REQUIREMENT 13: HANDLING, STORAGE AND SHIPPING

13-200 Special requirements

ASME NQA-1 requires the organization to specify, provide and verify theexistence of special equipment and special protective environments, whenrequired.

13-400 Tools and equipment

ASME NQA-1 requires the organization to use, control, inspect and testspecial handling tools and equipment.

13-500 Operators

ASME NQA-1 requires the organization to use operators that areexperienced and/or trained in the use of special handling and lifting equipment.


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13-600 Marking or labelling

ASME NQA-1 requires the organization to use marking or labelling, asnecessary, to maintain and preserve the item.

REQUIREMENT 17: QUALITY ASSURANCE RECORDS

17-300 Authentication of records

ASME NQA-1 requires the organization to consider documents as validrecords only after they have been authenticated.

17-500 Receipt control of records

ASME NQA-1 requires the organization to designate a person ororganization responsible for receiving records and to provide a method forcontrolling the receipt of records.

17-600 Storage

ASME NQA-1 requires the organization to store records at a predeterminedlocation(s) in a manner that minimizes the risk of loss, damage or destruction.

REQUIREMENT 18: AUDITS

18-200 Scheduling

ASME NQA-1 requires the organization to schedule audits.

18-400 Performance

ASME NQA-1 requires the organization to conduct audits against specifiedrequirements, using the examination of objective evidence to determine effectiveimplementation of the requirements.


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18-500 Reporting

ASME NQA-1 requires the organization to ensure that the lead auditorendorses the audit report and issues it to the audited organization. It also specifiesthe contents of the audit report.

18-800 Records

ASME NQA-1 specifies requirements for audit records.

The extent to which IAEA GS-R-3 addresses ASME NQA-1 requirementsis shown in Table 1. For copyright reasons, the text of ASME NQA-1 is not

included in this table. Keywords are included, as appropriate, to help the readeridentify the nature of the requirements. Users should refer to ASME NQA-1 forthe full text of the requirements.

TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1

REQUIREMENTS

Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3

1 Organization

1-100 Basic

Keywords:

Responsibilities, organizational

structure, functional responsibilities,

levels of authority, lines of

communication.

Requirements in paras 2.8, 3.12 and 3.14.

1-200 Structure and responsibility

201 GeneralKeywords:

(a) Management expectations;

(b) Quality achieved and maintained by;

(c) Quality achievement verified by

(d) Sufficient authority, direct access,

organizational freedom, access to

work, independence, verification

functions.

202 Delegation of work

Requirements in paras 2.1, 2.2, 2.4, 3.12,3.13, 3.14, 5.7, 5.10 and 6.5.

IAEA GS-R-3 users should address

organizational freedom, independence of

verification activities and the following

verification functions:

(1)Identifying quality problems;(2) Initiating, recommending or providing

solutions to quality problems through

designated channels;(3)Verifying implementation of solutions;


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(4) Ensuring that further processing,

delivery, installation or use is controlled

until proper disposition of a non-

conformance, deficiency or

unsatisfactory condition has occurred.

1-300 Interface control


2 Quality assurance programme

2-100 Basic

Keywords:

(a) Documented planned,

implemented, maintained;

(c) Management assessment.

Requirements in paras 2.1, 2.6, 2.7, 3.8, 4.1,

4.2, 4.4, 4.5 and 6.

IAEA GS-R-3 users should establish the

programme at the earliest time consistent

with the schedule for accomplishing the

activities and provide for special controls,

as required by ASME NQA-1 (see notes

under 2-2002-500 for additional details).

2-200 Indoctrination and training

201 Indoctrination

202 Training

Requirements in paras 4.3 and 4.4.

IAEA GS-R-3 users should ensure that the

description and introduction of the job

responsibilities and authority includes

general criteria, technical objectives,

requirements of applicable codes and

standards, regulatory commitments,

company procedures and quality assurancerequirements as required by ASME NQA-

1. IAEA GS-R-3 users should conduct an

introduction and training commensurate

with the scope, complexity and importance

of the activities, and with the education,

experience and proficiency of the person,

consistent with the grading requirements in

IAEA GS-R-3 paras 2.6 and 2.7.


REQUIREMENTS (cont.)



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2-300 Qualification requirements

Keywords:

Designate activities that require

qualification, written procedures.

301 Non-destructive examination

(NDE)

302 Inspection and test

303 Lead auditor

303.1 Communication skills

303.2 Training

303.3 Audit participation

303.4 Examination

303.5 Maintenance of proficiency

303.6 Requalification

304 Auditors

305 Technical specialists

No corresponding requirements.

IAEA GS-R-3 users should ensure that the

responsible organization designates those

activities that require qualification. The

minimum requirements for personnel to

verify quality and auditing are specified in

paras 301304 of this ASME NQA-1

requirement. Consult relevant parts ofASME NQA-1 for guidance on

implementation of this requirement.

2-400 Records of qualification

No corresponding requirement.

IAEA GS-R-3 users should address this

ASME NQA-1 requirement.

2-500 Records

Requirement in para. 5.21.

IAEA GS-R-3 users should ensure that

records of the implementation of

introduction and training include one or

more of (a) through (c) of this ASME

NQA-1 requirement.





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IAEA GS-R-3 users should establish and

maintain records of auditor and lead auditor

qualification and requalification, and of

inspection and test personnel qualification

and requalification.

3 Design control

3-100 Basic

Keywords:

Defined, controlled.

No corresponding specific requirement.

IAEA GS-R-3 paras 5.15.10 addressprocess management in general. IAEA

GS-R-3 users should address this ASME

NQA-1 requirement. Consult relevant parts

of ASME NQA-1 for guidance on


3-200 Design input


IAEA GS-R-3 para. 5.4 addresses process

inputs. IAEA GS-R-3 users should addressthis ASME NQA-1 requirement. Consult

relevant parts of ASME NQA-1 for

guidance on implementation of this

requirement.

3-300 Design process

Keywords:

(a) Prescribe and document the design

activities, (b) design methods and (c)

final design, commercial grade items

and services.


IAEA GS-R-3 para. 5.14 addresses control

of products. IAEA GS-R-3 users should

address this ASME NQA-1 requirement.Consult relevant parts of ASME NQA-1 for


requirement.

3-400 Design analyses

401 Use of computer programs

402 Documentation of design

analyses

No corresponding specific requirements.

IAEA GS-R-3 users should address these

ASME NQA-1 requirements. Consult


guidance on implementation of theserequirements.





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3-500 Design verification

501 Methods

501.1 Design reviews

501.2 Alternate calculations

501.3 Qualification tests

No corresponding specific requirements.




guidance on implementation of these

requirements.

3-600 Change control

Keywords:

(a) Changes to design justified,

evaluation of effects, approved,

approving organization, demonstrated

competence, (c) incorrect design.

601 Configuration management of

operating facilities


IAEA GS-R-3 para. 5.13 addresses changes

to documents. IAEA GS-R-3 users should

address this ASME NQA-1 requirement.

Consult relevant parts of ASME NQA-1 for


requirement.

3-700 Interface control

Keywords:Responsibility, procedures, design

information.


IAEA GS-R-3 para. 5.5 addresses the

control of interfaces generally. IAEAGS-R-3 users should address this ASME




3-800 Software design control

801 Software design process

801.1 Identification of software

design requirements

801.2 Software design

801.3 Implementation of the

software design

801.4 Software design verification

801.5 Computer program testing


IAEA GS-R-3 paras 5.3, 5.9 and 5.10

address process management in general.





requirements.





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802 Software configuration

management

802.1 Configuration identification

802.2 Configuration change control

802.3 Configuration status control

3-900 Documentation and records

Keywords:Sources of design inputs.


IAEA GS-R-3 paras 5.65.10 address

process management generically. These

generic requirements address process

documentation and records to demonstrate

the achievement of process results. IAEA

GS-R-3 paras 5.12 and 5.13 address

document control, and paras 5.21 and5.22 address records. IAEA GS-R-3 users

should address this ASME NQA-1requirement. Consult relevant parts of

ASME NQA-1 for guidance on


4 Procurement document control

4-100 Basic

Keywords:

Design bases, suppliers, quality

assurance programme.



design bases are addressed in thedocuments, if applicable.

4-200 Content of the procurement

documents

Keywords:

All tiers of procurement.

201 Scope of work

202 Technical requirements



ASME NQA-1 requirements. Procurement

documents should include the scope,

technical requirements, quality assurance





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203 Quality assurance programme

requirements

204 Right of access

205 Documentation requirements

206 Non-conformances

207 Spare and replacement parts

requirements, purchaser right of access,

documentation requirements, non-

conformance reporting provisions, and

spare and replacement parts. Consult



requirements.

4-300 Procurement document review



ASME NQA-1 requirement, including

documented changes to procurement

documents prior to award, to ensure that

documents transmitted to a prospective

supplier include the appropriate provisions

for ensuring that items or services will meetthe specified requirements. Consult



requirement.

4-400 Procurement document changes


5 Instructions, procedures and

drawings

5-100 Basic

Keywords:

Documented, quantitative or

qualitative acceptance criteria, detail

commensurate with complexity.

Requirements in paras 2.62.10, 4.3, 5.6,

5.7 and 5.9.

6 Document control

6-100 Basic


6-200 Document control






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6-300 Document changes

301 Major changes

302 Minor changes


7 Control of purchased items and services

7-100 Basic

Requirements in paras 5.15, 5.16, 5.23,

5.24 and 6.3.

7-200 Supplier evaluation and selection


IAEA GS-R-3 users should address one or

more of the following: suppliers history,

suppliers current quality records,

suppliers technical and quality capability.

7-300 Bid evaluation



ASME NQA-1 requirement. Consult



requirement.

7-400 Control of supplier generated documents


When supplier documents are received,the requirements in IAEA GS-R-3paras 5.12, 5.21 and 5.24 provide the

necessary controls. IAEA GS-R-3 users

should address this ASME NQA-1

requirement. Consult relevant parts of







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7-500 Acceptance of item or service

501 General

Keywords:

Supplier shall verify.

502 Methods of acceptance

503 Certificate of conformance

504 Source verification

505 Receiving inspection

506 Post-installation testing

507 Acceptance of services only


IAEA GS-R-3 users should address paras

503507 of ASME NQA-1.

7-600 Control of supplier non-conformances

Keywords:

(a) evaluation, (b) submittal,(c) disposition, (d) verification,(e) records.

Requirements in paras 5.25 and 6.116.16.


600(a)(e) of ASME NQA-1.

7-700 Commercial grade items and services

701 General No corresponding requirement.





requirement.

7-800 Records






requirement.





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8 Identification and control of items

8-100 Basic

Keywords:

Correct and accepted items.


8-200 Identification methods

201 Item identification

202 Physical identification



ASME NQA-1 requirements. Consultrelevant parts of ASME NQA-1 for


requirements.

8-300 Specific requirements

301 Identification and traceability

of items

302 Limited life items

303 Maintaining identification of

stored items




relevant parts of ASME NQA-1 forguidance on implementation of these

requirements.

9 Control of special processes

9-100 Basic

Keywords:

Welding, heat treating, non-

destructive examination, qualified

personnel, qualified procedures.




relevant parts of ASME NQA-1 forguidance on implementation of this

requirement.

9-200 Process control

201 Special processes

202 Acceptance criteria

203 Special requirements






requirements.





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9-300 Responsibility






requirement.

9-400 Records






requirement.

10 Inspection

10-100 Basic



inspection for acceptance is performed by

qualified persons other than those who

performed or directly supervised the work.

10-200 Inspection requirements

Requirement in para 5.7.

When specifying inspection requirements

and acceptance criteria, IAEA GS-R-3

users should include specified requirements

contained in the applicable design

documents or other pertinent technical

documents approved by the responsible

design organization.





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10-300 Inspection hold points



ASME NQA-1 requirement. Specified hold

points should be indicated in appropriate

documents. Consult relevant parts of



10-400 Inspection planning

401 Planning

402 Sampling






requirements.

10-500 In-process inspection






requirement.

10-600 Final inspections

601 Resolution ofnon-conformances

602 Inspection requirements

603 Modifications, repairs or

replacements

604 Acceptance






requirements.





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10-700 Inspections during operations






requirement.

10-800 Records






requirement.

11 Test control

11-100 Basic

Keywords:

Collect data, verify conformance,demonstrate satisfactory performance.


IAEA GS-R-3 users should specify

characteristics to be tested and test methods

to be employed. Test results shall be

documented and their conformance with

test requirements and acceptance criteria

shall be evaluated.

11-200 Test requirements






11-300 Test procedures (other than for computer programs)

Keywords:

Test configuration, test objectives,

prerequisites.






requirement.





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11-400 Computer program test procedures






requirement.

11-500 Test result






requirement.

11-600 Test records

601 Test records

602 Computer program test

records






requirements.

12 Control of measuring and test equipment

12-100 Basic


IAEA GS-R-3 users should address control,

calibration at specific periods, adjustment

and maintenance of tools, gauges,

instruments, and other measuring and test

equipment.

12-200 Selection






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12-300 Calibration and control

301 Calibration

302 Reference standards

303 Control

303.1 Application

303.2 Corrective action

303.3 Handling and storage

303.4 Environmental controls

303.5 Pre-calibration checks

303.6 Status indication

304 Commercial devices






requirements.

12-400 Records

401 General

Keywords:

Status, capability.

402 Reports and certificates






requirements.

13 Handling, storage and shipping

13-100 Basic



cleaning and packaging of items.





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13-200 Special requirements

Keywords:

Equipment, protective environment.




relevant parts of ASME NQA-1-1 for


requirement, as applicable.

13-300 Procedures


13-400 Tools and equipment






requirement.

13-500 Operators






requirement.

13-600 Marking or labelling






requirement.





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14 Inspection, test and operating status

14-100 Basic

Keywords:

Identified, maintained through

indicators, authority.



inspection, test and operating status, as

required by ASME NQA-1.

15 Control of non-conforming items

15-100 Basic



notification of affected organizations.

15-200 Identification


IAEA GS-R-3 users should address the use

of identification methods not detrimental tothe item, on the item, the container or the

package.

15-300 Segregation


IAEA GS-R-3 users should employ

precautions to preclude inadvertent use of a

non-conforming item in cases where

segregation is impractical or impossibledue to physical conditions such as size,

weight or access limitations.

15-400 Disposition

401 Control

402 Responsibility and authority

403 Personnel

404 Disposition

405 Re-examination



402 and 403 of ASME NQA-1.





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16 Corrective action

16-100 Basic

Keywords:

Condition adverse to quality,

significant.



verification of completed corrective

actions.

17 Quality assurance records

17-100 Basic



authentication.

17-200 Generation of records


17-300 Authentication of records

Keywords:(a) valid, (b) electronic.






requirement.

17-400 Classification

401 Lifetime records

402 Non-permanent records




17-500 Receipt control of records






requirement.





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17-600 Storage

601 General

Keywords:(a) location, minimize risk,(b) detrimental activities, (c) access,

(d) damage.

602 Facility types

Keywords:

(602.1) single, (602.2) dual.

603 Temporary storage






requirements.

17-700 Retention


17-800 Maintenance of records

Keywords:

(a) protected, (b) retrievability,(c) methods for record changes,(d) electronic record media,(e) technology changes, (f) duplicated.


IAEA GS-R-3 users should address (b)

through (f) of ASME NQA-1.

18 Audits

18-100 Basic

Requirements in paras 5.9, 6.3, 6.5 and 6.6.

18-200 Scheduling


IAEA GS-R-3 users should address thisASME NQA-1 requirement. Consult



requirement.

18-300 Preparation

301 Audit plan

302 Personnel

303 Selection of audit team








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18-400 Performance






requirement.

18-500 Reporting






requirement.

18-600 Response



evaluation of audit responses by or for the

auditing organization.

18-700 Follow-up action


18-800 Records






requirement.





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4. EXTENT TO WHICH ASME NQA-1 ADDRESSESIAEA GS-R-3 REQUIREMENTS

This section describes the extent to which ASME NQA-1 addresses the IAEAGS-R-3 requirements. It identifies where the requirements are equivalent andprovides guidance on how to modify an ASME NQA-1 QA programme to meetIAEA GS-R-3 requirements. Table 2 lists all five elements of IAEA GS-R-3, aswell as the specific requirements of each. In this table, where a particular ASMENQA-1 requirement meets the specific IAEA GS-R-3 requirement, it is so stated.Where no ASME NQA-1 element meets the IAEA GS-R-3 requirement, guidanceis provided on how the IAEA GS-R-3 requirement could be met. Where applicable,

reference is made to IAEA Safety Guides GS-G-3.1 [2] and GS-G-3.5 [3] foradditional guidance on how IAEA GS-R-3 requirements could be met. Thecorrelation between the requirements in ASME NQA-1 and those in IAEA GS-R-3is presented in Appendix II.

The following presents those IAEA GS-R-3 requirements for which there isNo corresponding requirement in ASME NQA-1, as identified in Table 2 (seepage 37). The numbering in the table corresponds to IAEA GS-R-3.

4.1. MANAGEMENT SYSTEM

IAEA GS-R-3, para. 2.3, requires the following requirements to beidentified and integrated into the management system:

The statutory and regulatory requirements of the Member State; Any requirements formally agreed with interested parties (also known as

stakeholders); All other relevant IAEA Safety Requirements publications, such as those on

emergency preparedness and response and on safety assessment; Requirements from other relevant codes and standards adopted for use by

the organization.

4.1.1. Safety culture

IAEA GS-R-3, para. 2.5, requires the management system to promote andsupport a strong safety culture. Specific requirements relate to: a common

understanding of the key aspects of safety; support to individuals and teams incarrying out tasks safely; reinforcing a learning and questioning attitude; andcontinual improvement of the safety culture.


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4.1.2. Management commitment

IAEA GS-R-3, para. 3.2, requires senior management to develop individualvalues, institutional values and behavioural expectations for the organization tosupport the implementation of the management system and act as role models inthe promulgation of these values and expectations.

IAEA GS-R-3, para. 3.3, requires management at all levels to communicateto individuals the need to adopt these individual values, institutional values andbehavioural expectations that have been developed by senior management as wellas the need to comply with the requirements of the management system.

IAEA GS-R-3, para. 3.4, requires management at all levels to foster theinvolvement of all individuals in the implementation and continual improvement

of the management system.

4.1.3. Satisfaction of interested parties

IAEA GS-R-3, para. 3.6, requires senior management to consider theexpectations of interested parties in the activities and interactions in the processesof the management system. The aim is to enhance the satisfaction of theinterested parties without compromising safety.

4.1.4. Organizational policies

IAEA GS-R-3, para. 3.7, requires senior management to develop policiesthat are appropriate for the activities and facilities of the organization.

4.1.5. Planning

IAEA GS-R-3, para. 3.10, requires senior management to ensure thatmeasurable objectives are established through appropriate processes at variouslevels of the organization for implementing the organizations goals, strategiesand plans.

IAEA GS-R-3, para. 3.11, requires senior management to ensure that theimplementation of the organizations goals, strategies and plans is regularlyreviewed against the measurable objectives and that actions are taken to addressdeviations from the implementation plans, where necessary.

4.1.6. Responsibility, authority and communication

IAEA GS-R-3, para. 3.13, requires an individual reporting directly to seniormanagement to have specific responsibility and authority for: coordinating the


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development and implementation of the management system, and its assessmentand continual improvement; reporting on the performance of the managementsystem, including its influence on safety and safety culture, and any need forimprovement; and resolving any potential conflicts between requirements andwithin the processes of the management system.

4.1.7. Provision of resources

IAEA GS-R-3, para. 4.1, requires senior management to determine thenecessary resources, and to provide those resources to carry out the activities ofthe organization and to establish, implement, assess and continually improve themanagement system.

IAEA GS-R-3, para. 4.2, requires that the information and knowledge ofthe organization be managed as resources.

4.1.8. Developing processes

IAEA GS-R-3, para. 5.2, requires the determination of the sequence andinteractions of the processes of the management system needed to achieve thegoals, to provide the means to meet all requirements and to deliver the products ofthe organization.

4.1.9. Process management

IAEA GS-R-3, para. 5.6, requires that an individual be designated for eachprocess. This individual, normally referred to as the process owner, has theauthority and responsibility to manage the process. The process owner has thespecific authority and responsibility to: develop and document the process and tomaintain the necessary supporting documentation; ensure that there is effectiveinteraction between interfacing processes; ensure that process documentation isconsistent with any existing documents; ensure that the records required todemonstrate that the process results have been achieved are specified in theprocess documentation; monitor and report on the performance of the process;promote improvement in the process; and ensure that the process, including anysubsequent changes to it, is aligned with the goals, strategies, plans andobjectives of the organization.


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4.1.10. Generic management system processes

IAEA GS-R-3, para. 5.11, requires the development of generic processes inthe management system that include communication and managingorganizational change.

4.1.11. Communication

IAEA GS-R-3, para. 5.26, requires that information relevant to safety,health, environmental, security, quality and economic goals be communicated toindividuals in the organization and, where necessary, to other interested parties.

IAEA GS-R-3, para. 5.27, requires internal communication between the

various levels and functions of the organization concerning the implementationand effectiveness of the management system.

4.1.12. Managing organizational change

IAEA GS-R-3, para. 5.28, requires that organizational changes be evaluatedand classified according to their importance to safety and their justification.

4.1.13. Self-assessment

IAEA GS-R-3, para. 6.2, requires senior management and management atall other levels in the organization to carry out self-assessments to evaluate theperformance of work and the improvement of the safety culture.

4.1.14. Management system review

IAEA GS-R-3, para. 6.8, requires that the management system reviewcover, but not be limited to: outputs from all forms of assessment; resultsdelivered and objectives achieved by the organization and its processes; non-conformances and corrective and preventive actions; lessons learned from otherorganizations; and opportunities for improvement.

IAEA GS-R-3, para. 6.9, requires that weaknesses and obstacles beidentified, evaluated and remedied in a timely manner.

IAEA GS-R-3, para. 6.10, requires that the management system reviewidentify whether there is a need to make changes to, or improvements in, policies,goals, strategies, plans, objectives and processes.


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4.1.15. Non-conformances and corrective and preventive actions

IAEA GS-R-3, para. 6.16, requires that potential non-conformances thatcould detract from the organizations performance be identified using: feedbackfrom other organizations, both internal and external; technical advances andresearch; the sharing of knowledge and experience; and techniques that identifybest practices.

4.1.16. Improvement

IAEA GS-R-3, para. 6.17, requires that opportunities for improvement ofthe management system be identified and actions to improve the processes be

selected, planned and recorded.IAEA GS-R-3, para. 6.18, requires that plans to improve the managementsystem include the provision of adequate resources. It also requires thatimprovement actions be monitored through to their completion and that theeffectiveness of the improvements be checked.

TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3REQUIREMENTS

IAEA-GS-R-3

para. No.IAEA GS-R-3 requirement

Notes to aid users

of ASME NQA-1

2.12.10 Management system

General requirement

2.1 A management system shall be established,

implemented, assessed and continually

improved. It shall be aligned with the goals of

the organization and shall contribute to their

achievement. The main aim of the management

system shall be to achieve and enhance safety

by:

Bringing together in a coherent manner all therequirements for managing the organization;

Describing the planned and systematic actionsnecessary to provide adequate confidence that

all these requirements are satisfied;

Ensuring that health, environmental, security,quality and economic requirements are not

considered separately from safety

requirements, to help preclude their possiblenegative impact on safety.

Requirements 1 and 2.

ASME NQA-1 users should

ensure that health, safety,

environmental, security and

economic requirements will be

implemented as part of continual

improvement of the

management system.


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2.2 Safety shall be paramount within the

management system, overriding all other

demands.

No corresponding specific

requirement, but Part I,

Introduction, addresses the safe

utilization of nuclear energy and

nuclear material processing.


address safety to the extent

described by IAEA GS-R-3 to

ensure that safety is paramount.2.3 The management system shall identify and

integrate with the requirements contained within

IAEA GSR-R-3:

The statutory and regulatory requirements ofthe Member State;

Any requirements formally agreed withinterested parties (also known as

stakeholders);

All other relevant IAEA Safety Requirements

publications, such as those on emergencypreparedness and response and safety

assessment;

Requirements from other relevant codes andstandards adopted for use by the organization.



address this IAEA GS-R-3

requirement. Consult IAEA

GS-G-3.1, paras 2.12.6 and

appendix I, for guidance on

implementation of this

requirement.

2.4 The organization shall be able to demonstrate the

effective fulfilment of its management system

requirements.

Requirement 2, Section 100 (c).


address all aspects of

management system

requirements.

Safety culture

2.5 The management system shall be used to

promote and support a strong safety culture by:

Ensuring a common understanding of the keyaspects of safety culture within the

organization;

Providing the means by which theorganization supports individuals and teams

in carrying out their tasks safely and

successfully, taking into account theinteraction between individuals, technology

and the organization;



address this IAEA GS-R-3


GS-R-3, paras 2.322.36, for

guidance on implementation of

this requirement.

TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3REQUIREMENTS (cont.)

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2.5 (cont.) Reinforcing a learning and questioningattitude at all levels of the organization;

Providing the means by which theorganization continually seeks to develop and

improve its safety culture.

Grading the application of management system requirements

2.6 The application of management system

requirements shall be graded so as to deploy

appropriate resources, on the basis of theconsideration of:

The significance and complexity of eachproduct or activity;

The hazards and the magnitude of thepotential impact (risks) associated with the

safety, health, environmental, security, quality

and economic elements of each product or

activity;

The possible consequences if a product failsor an activity is carried out incorrectly.

Requirement 2, Section 100 (a),

Requirement 5, Part I,

Introduction.


deploy appropriate resources

based on the potential impact

associated with the safety,

health, environmental, security

and economic aspects of the

product or activity in the

application of the QA

programme. See also Part III,

Subpart 2A-2, for additionalguidance.

2.7 Grading of the application of management

system requirements shall be applied to the

products and activities of each process.

Requirement 2, Section 100 (a),

Requirement 5, Part I,

Introduction.

Requirement 3, Section 500 (d),

Requirement 3, para. 801.4 (b),

Requirement 4, para. 203,

Requirement 6, Section 300,

Requirement 7, para. 501, and

Requirement 7, para. 504 are

examples of a graded approach.


address the potential impact

associated with the safety,


and economic aspects of the

products and activities of each

process in the application ofthe QA programme. See also

Part III, Subpart 2A-2, for

additional guidance


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Documentation of the management system

2.8 The documentation of the management system

shall include the following:

The policy statements of the organization;A description of the management system;A description of the structure of the

organization;

A description of the functionalresponsibilities, accountabilities, levels of

authority and interactions of those managing,

performing and assessing work;

A description of the processes and supportinginformation that explain how work is to be

prepared, reviewed, carried out, recorded,

assessed and improved.

Requirements 1 and 2.

Other NQA-1 requirements

include responsibilities specific

to processes and activities.


address, in the documentation of

the management system, all

IAEA GS-R-3 requirements, i.e.

policy statements, and safety,


and economic elements.


shall be developed to be understandable to those

who use it. Documents shall be readable, readily

identifiable and available at the point of use.

Requirements 1, 2, 6 and 17.


shall reflect:

The characteristics of the organization and itsactivities;

The complexities of processes and theirinteractions.

Requirement 2, Section 100 (a)

and Part I, Introduction.


address, in the documentation of

the management system, the

potential impact associated with

the safety, health,

environmental, security and

economic aspects on products inthe processes. See also Part III,

Subpart 2A-2, for additional

guidance.

The organization should identify

all processes and their

interactions.


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3.13.14 Management responsibility

Management commitment

3.1 Management at all levels shall demonstrate its

commitment to the establishment,

implementation, assessment and continual

improvement of the management system and

shall allocate adequate resources to carry out

these activities.

Requirement 1 addresses

commitment to the

establishment and

implementation of the QA

programme.

Requirement 2, Section 100 (c),

addresses the assessment of theQA programme.


address continual improvement,

resource allocation and all other

areas of the management

system.

3.2 Senior management shall develop individual

values, institutional values and behavioural

expectations for the organization to support theimplementation of the management system and

shall act as role models in the promulgation of

these values and expectations.


Requirement 1, para. 201 (a)addresses overall management

expectations for the QA

programme. NQA-1 users

should address this IAEA GS-R-3


GS-R-3, paras 3.13.7, for

guidance on implementation of

this ASME NAQ-1 requirement.